Insulet Corporation
Staff Product Performance Engineer (Hybrid - Acton, MA)
Insulet Corporation - Acton, Massachusetts, United States, 01720
Work at Insulet Corporation
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Overview
Staff Product Performance Engineer
As a Staff Product Performance Engineer at Insulet Corporation, you will play a critical role in supporting our ISO 13485-certified Quality Management System (QMS) within a dynamic and fast-growing medical device environment. Reporting to the Director of Quality Systems, you will be responsible for leading and managing multiple Corrective and Preventive Actions (CAPAs), with a focus on both product performance and cloud-based software systems. Responsibilities: Responsible for managing, leading, and completing Product and Cloud Software CAPA phases effectively and on time from issue identification to resolution and verification of effectiveness. Partner with Product Software, Cloud Software, Product Owners, and Software Quality Assurance teams to ensure CAPA deadlines are met. Work with CAPA Process Owner to ensure Product and Cloud Software CAPAs are managed efficiently and effectively. Mentor other CAPA owners on the execution of CAPAs. May be responsible for planning and tracking CAPA performance against key performance indicators (KPIs). Assist in the development, implementation, and maintenance of the quality system and its procedures. In conjunction with the Quality Systems Director, maintain QMS compliance with Medical Device Single Audit Program and ISO 13485. Suggest methods for and improve quality system effectiveness, with emphasis on preventive action. Education and Experience: Bachelor of Science or equivalent degree. 7+ Experience working as a Hardware, Software Systems Engineer or with Systems Engineering responsibilities in a multidisciplinary project team environment. Demonstrated expertise in leading CAPAs. Experience in leading a cross-functional development team is preferred. Domain expertise in one or more associated domains; preferably Systems or Software Engineering, with exposure to Mechanical, Quality, and Test Engineering. Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments. Demonstrated expertise in Root Cause Investigation techniques such as 5-Whys, Fishbone, Is/Is not, etc. Demonstrated knowledge of and experience with the application of 21CFR820 and ISO 13485. Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes software development, software testing, cloud, quality design assurance, regulatory and quality experts. Knowledgeable of product development lifecycle, including software and or disposable development. Ability to foster teamwork to work cooperatively and effectively with team members. Demonstrated flexibility and ability to function in a fast-paced, growth industry and work environment. Preferred Skills/Competencies: Initiative to identify opportunities for improvements. Interpersonal skills to promote and accomplish constructive solutions to problems. High level of attention to detail and accuracy. Excellent organizational, problem-solving and communication skills. Ability to prioritize work and handle multiple assignments, while maintaining quality. Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner. Ability to work effectively between multiple levels within the organization. Advanced user skills in Microsoft Word, Excel, and PowerPoint. Note: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office at least three (3) days per week.
As a Staff Product Performance Engineer at Insulet Corporation, you will play a critical role in supporting our ISO 13485-certified Quality Management System (QMS) within a dynamic and fast-growing medical device environment. Reporting to the Director of Quality Systems, you will be responsible for leading and managing multiple Corrective and Preventive Actions (CAPAs), with a focus on both product performance and cloud-based software systems. Responsibilities: Responsible for managing, leading, and completing Product and Cloud Software CAPA phases effectively and on time from issue identification to resolution and verification of effectiveness. Partner with Product Software, Cloud Software, Product Owners, and Software Quality Assurance teams to ensure CAPA deadlines are met. Work with CAPA Process Owner to ensure Product and Cloud Software CAPAs are managed efficiently and effectively. Mentor other CAPA owners on the execution of CAPAs. May be responsible for planning and tracking CAPA performance against key performance indicators (KPIs). Assist in the development, implementation, and maintenance of the quality system and its procedures. In conjunction with the Quality Systems Director, maintain QMS compliance with Medical Device Single Audit Program and ISO 13485. Suggest methods for and improve quality system effectiveness, with emphasis on preventive action. Education and Experience: Bachelor of Science or equivalent degree. 7+ Experience working as a Hardware, Software Systems Engineer or with Systems Engineering responsibilities in a multidisciplinary project team environment. Demonstrated expertise in leading CAPAs. Experience in leading a cross-functional development team is preferred. Domain expertise in one or more associated domains; preferably Systems or Software Engineering, with exposure to Mechanical, Quality, and Test Engineering. Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments. Demonstrated expertise in Root Cause Investigation techniques such as 5-Whys, Fishbone, Is/Is not, etc. Demonstrated knowledge of and experience with the application of 21CFR820 and ISO 13485. Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes software development, software testing, cloud, quality design assurance, regulatory and quality experts. Knowledgeable of product development lifecycle, including software and or disposable development. Ability to foster teamwork to work cooperatively and effectively with team members. Demonstrated flexibility and ability to function in a fast-paced, growth industry and work environment. Preferred Skills/Competencies: Initiative to identify opportunities for improvements. Interpersonal skills to promote and accomplish constructive solutions to problems. High level of attention to detail and accuracy. Excellent organizational, problem-solving and communication skills. Ability to prioritize work and handle multiple assignments, while maintaining quality. Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner. Ability to work effectively between multiple levels within the organization. Advanced user skills in Microsoft Word, Excel, and PowerPoint. Note: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office at least three (3) days per week.